Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00162565
Status:
COMPLETED
Last Update Posted:
2009-05-25
First Post:
2005-09-09
Brief Title:
Beta-Blocker Continuation Versus Interruption in Heart Failure Worsening
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Beta-Blocker Continuation Versus Interruption in Patients With Congestive Heart Failure Hospitalized for Heart Failure Worsening B-CONVINCED
Status:
COMPLETED
Status Verified Date:
2005-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BConvinced
Brief Summary:
The objective of the B-Convinced study is to demonstrate the non-inferiority of beta-blocker continuation compared to its interruption in patients with congestive heart failure who are treated by a beta-blocker and present with an episode of heart failure worsening with pulmonary oedema requiring hospital admission
162 patients will be randomized in cardiology centers in France Clinical status primary endpoint will be evaluated with a standardized questionnaire 3 days after hospital admission
162 patients will be randomized in cardiology centers in France Clinical status primary endpoint will be evaluated with a standardized questionnaire 3 days after hospital admission
Detailed Description:
Therapeutic strategy of beta-blocker treatment during an episode of heart failure worsening remains unclear The objective of the B-Convinced study is to demonstrate that continuation of beta-blocker treatment in case of hospitalisation for heart failure worsening is as safe as the interruption of such treatment
Hypothesis The proportion of patients clinically improving within 3 days is not inferior when beta-blocker treatment is maintained compared to beta-blocker interruption in case of hospitalisation for heart failure worsening with pulmonary oedema
Design Open randomized non-inferiority trial on two parallel groups of patients Randomization performed centrally with a vocal server
Tested Hypothesis 90 of success in the interruption group power of 80 non-inferiority limit of 15 relative reduction 162 patients are required with such a hypothesis
Primary Endpoint Clinical improvement within 3 days of hospital admission evaluated by the investigator by a standardized questionnaire
Secondary Endpoints Clinical improvement at day 8 or at hospital discharge morbidity-mortality at 4 months
34 participating centres in France
Hypothesis The proportion of patients clinically improving within 3 days is not inferior when beta-blocker treatment is maintained compared to beta-blocker interruption in case of hospitalisation for heart failure worsening with pulmonary oedema
Design Open randomized non-inferiority trial on two parallel groups of patients Randomization performed centrally with a vocal server
Tested Hypothesis 90 of success in the interruption group power of 80 non-inferiority limit of 15 relative reduction 162 patients are required with such a hypothesis
Primary Endpoint Clinical improvement within 3 days of hospital admission evaluated by the investigator by a standardized questionnaire
Secondary Endpoints Clinical improvement at day 8 or at hospital discharge morbidity-mortality at 4 months
34 participating centres in France
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None